Accolade® TMZF® Hip Stem Outcomes Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00957658
First received: August 10, 2009
Last updated: August 13, 2014
Last verified: August 2014
Results First Received: October 28, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Arthroplasty, Replacement, Hip
Intervention: Device: Accolade® TMZF® Hip Stem

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
241 participants/249 hips - 7 censored participants/7 hips = 234 participants/242 hips

Reporting Groups
  Description
Accolade® TMZF® Hip Stem Accolade® TMZF® Hip Stem Study Device. Participants have one or both hips replaced. If both hips were replaced, but only one hip completed the primary endpoint, the participant is counted as completed.

Participant Flow:   Overall Study
    Accolade® TMZF® Hip Stem  
STARTED     234  
COMPLETED     169  
NOT COMPLETED     65  
Death                 1  
Lost to Follow-up                 4  
Withdrawal by Subject                 12  
Revision                 1  
Incomplete 2 yr data                 28  
Site termination                 10  
unwilling/unable to return                 2  
surgery cancelled                 2  
Protocol Violation                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who were censored protocol violations or who were enrolled but did not have surgery or age data was not available, are not included in the baseline analysis.

Reporting Groups
  Description
Accolade® TMZF® Hip Stem Accolade® TMZF® Hip Stem Study Device

Baseline Measures
    Accolade® TMZF® Hip Stem  
Number of Participants  
[units: participants]
  234  
Age [1]
[units: years]
Mean ± Standard Deviation
  68.94  ± 9.77  
Gender [2]
[units: participants]
 
Female     149  
Male     80  
Region of Enrollment  
[units: participants]
 
United States     234  
[1]
  1. Age results are based on 226 participants as there were 8 participants missing age data.
  2. For bilateral total hip replacement participants, the age at the time of the initial hip surgery is used.
[2] Gender is based on 229 participants as there were 5 participants missing gender data.



  Outcome Measures

1.  Primary:   Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain   [ Time Frame: 2 years ]

2.  Secondary:   Aseptic Femoral Stem Loosening   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Femoral Stem Fracture   [ Time Frame: 2 and 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Harris Hip Score, SF-12, KAS and PEQ   [ Time Frame: 2 and 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Acetabular Insert Wear   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   DXA Scan Analysis   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director of Clinical Research
Organization: Stryker Orthopaedics
phone: 201-831-5401
e-mail: Ellen.Axelson@stryker.com


No publications provided


Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT00957658     History of Changes
Other Study ID Numbers: 59
Study First Received: August 10, 2009
Results First Received: October 28, 2013
Last Updated: August 13, 2014
Health Authority: United States: Institutional Review Board